Pitt Gets Grants Totaling $17.5 Million For Two HIV-Prevention Projects

A multicenter research team led by the University of Pittsburgh is developing microbicides specifically designed to prevent rectal transmission of HIV. The team will also assess the microbicides’ safety and efficacy in lab and early clinical studies.

The Combination HIV Antiretroviral Rectal Microbicide (CHARM) program will be funded by an $11 million, five-year grant from the National Institutes of Health (NIH). The program includes a project that will reformulate existing antiretroviral drugs into topical preparations that can be applied to the rectum, said principal investigator Ian McGowan, a professor of medicine and of obstetrics, gynecology, and reproductive sciences in Pitt’s School of Medicine.

“Unprotected receptive anal intercourse is the highest-risk sexual activity for HIV transmission,” noted McGowan, who also is an investigator in the Magee-Womens Research Institute. “Vaginal microbicides already are being extensively studied, and a similar approach might be a very effective way of preventing rectal HIV transmission. It will be critical to determine whether vaginal microbicides are safe and effective when used in the rectum, and also to develop rectal-specific products.”

The rectal microbicides that the team develops will be assessed in human cell lines, intestinal tissue samples, and animal models. After candidate agents have been developed, the CHARM program will progress to studying them in human safety trials. Collaborating research centers include the University of California, Los Angeles; Johns Hopkins University; the University of North Carolina; and CONRAD, a program of the Eastern Virginia Medical School that receives substantial support from the U.S. Agency for International Development.

In addition, McGowan and Alex Carballo-Dieguez, a professor of clinical psychology in the Department of Psychiatry at Columbia University, are coprincipal investigators of a $6.5 million, four-year, NIH-funded project titled “Microbicide Safety and Acceptability in Young Men.” Carballo-Dieguez also is associate director and senior research scientist in the HIV Center for Clinical and Behavioral Studies at New York State Psychiatric Institute.

The Microbicide Safety and Acceptability in Young Men  study will be conducted in Pittsburgh, Boston, and Puerto Rico. HIV-negative men who are between 18 and 30 years old and who have sex with men will be counseled about safer sex practices and provided with condoms. They will then be asked to use a placebo gel during sexual encounters and inform the researchers about their experiences with the product through an automated phone system, video interviews with research assistants, and other means.

Those who are most strict about using the placebo gel will be asked to participate in the next stage of the study, which will test the rectal safety of a vaginal microbicide or a placebo.

“This project will give us greater knowledge of whether microbicides are safe, easy to use, and acceptable in the real world,” McGowan said.

The University of Pittsburgh also leads the NIH-funded Microbicide Trials Network (MTN), of which McGowan is a coprincipal investigator. Headquartered at Magee-Womens Research Institute in Pittsburgh, MTN is a global clinical trials network focused on preventing the sexual transmission of HIV.